BAYCOL Cerivastatin

For instance, in September 2004, Bayer settled 2861 product liability cases for 1.09 billion for its cholesterol medicine cerivastatin (Baycol), which was linked to 100 deaths and withdrawn from market in 2001. In July 2004, the company settled 2771 cases for 1.06 billion. Bayer still has 7577 additional cases to settle (see Section 28.4.4.5 for additional information). In another example, a 1 billion jury verdict was upheld against Wyeth for its fenfluramine or dexfenfluramine and phentermine (Fen-Phen) drug combination, which was linked to primary pulmonary hypertension (PPH). Wyeth has set aside 16.6 billion to cover future liability on the drug (see Section 28.4.4.2 for more on this case). ... 

Mevacor), got FDA clearance in the United States in August 1987. Along with lovastatin, there are currently six statin drugs on the market the others are simvastatin (Zocor), pravastatin (Pravacol), fluvastatin (Lescol), atorvastatin (Lipitor), and rosuvastatin (Crestor). A seventh statin, cerivastatin (Baycol), was taken off the market following drug-related deaths. 

In all honesty, the drugs appear to be relatively safe as a class. They have been used for two decades and have been prescribed to many millions of men and women around the world. Studies have demonstrated that they can prevent heart attacks and strokes and save lives by dramatically reducing cholesterol. Obviously, there were terrible problems with cerivastatin (Baycol). And the British medical journal The Lancet has asked for a recall of rosuvastatin (Crestor), citing poor research data and potential side effects involving the liver and the kidneys and muscle damage. Consumer advocates in the United States have also called for FDA to reverse its approval. 

Cerivastatin (Baycol) Cholesterol lowering Rhabdomyolysis Drug-drug interactions... 

Lovastatin (Mevacor ) (3), simvastatin (Zocor ) (15), pravastatin (Pravachol ) (19), atorvastatin (Lipitor ) (20), cerivastatin (Baycol , withdrawn on August 1, 2003) (21), and fluvastatin (Lescol ) (22) were introduced to lower total cholesterol levels, and especially LDL-cholesterol levels to prevent coronary heart disease. These HMG-CoA inhibitors inhibit de novo synthesis of cholesterol in the liver. The rate-limiting enzyme in cholesterol synthesis is HMG-CoA reductase, which catalyzes the conversion of HMG-CoA to mevalonate. The resulting decrease in hepatic cholesterol synthesis leads to increased synthesis of... 

Statins include atorvastatin calcium (Lipitor), cerivastatin (Baycol), fluvas-tatin (Lescol), lovastatin (Mevacor), pravastatin sodium (Pravachol), and simvastatin (Zocor). 

Fig. 7.1 Chemical structures of statins. Atorvastatin (Lipitor) (a) cerivastatin (Baycol) (b) ...

Cerivastatin sodium Baycol Bayer Cholesterollo- wering 6/26/1997 8/8/2001 4.17 years Rhabdomyolsis 554 million in 2000... 

Baycol (cerivastatin, sold as Lipobay in Europe, Bayer) is a statin, a class of cholesterol-lower drugs. Statins are the most prescribed drugs in the United States, with more than 12 million people taking them, and more than 700,000 people in the United States taking cerivastatin. It received marketing approval on June 26, 1997 and was voluntarily removed from the market on August 8, 2001 because of its link to 100 deaths and several injuries from potentially the muscle disease rhabdomyolysis. The other statins — lovas-tatin (Mevacor Merck) pravastatin (Pravachol Bristol-Myers Squibb) simvastatin (Zocor Merck) fluvastatin (Lescol Novartis) atorvastatin (Lipitor Parke-Davis) rosuvastatin... 

Cerivastatin. Ccrivasiatin (Baycol) is one of the newer agents in this class of cholesterol-lowering agents. It carries, however, a higher incidence of rhabdomyolysis and. as a result, was voluntarily withdrawn from the market by its manufacturer in 2001. 

Because of possible adverse effects on liver function, caution was advised when Baycol (cerivastatin sodium... 

Baycol (cerivastatin) was developed by Bayer A.G. and approved by the FDA for use in the United States in 1997. It is a member of a class of cholesterol-lowering drugs that are commonly referred to as statins . Statins such as Baycol lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. Although all statins have been associated with very rare reports of rhabdomyolysis, a muscle disorder, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins. On 8 August 2001, Bayer announced that it was voluntarily withdrawing Baycol from the US market because of reports of sometimes fatal rhabdomyolysis. 

Withdrawals from the market of ethically approved drugs in recent years [e.g., Pon-dimin (fenfluramine hydrochloride) and its sister compound Redux (dexfenflura-mine hydrochloride) for reasons of abnormal heart valve effects in 1996 Baycol/Li-pobay (cerivastatin) for occurrence of fatal rhabdomyolysis in 2001 Serzone (nefazo-dine) for associated Hver failure in 2003]... 

Cerivastatin Lipobay, Baycol Antiojddant/anti- inflammatory, antithrombotic 10.0 Rajamkemt et til. (2007), Vaughan (2003)... 

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